Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Influence of Prior Walking on Postprandial Metabolism and Endothelial Function in South Asian vs White European Women.
Verified date | May 2019 |
Source | Loughborough University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study will investigate the effect of prior walking on postprandial metabolism and
endothelial function in healthy South Asian and White European women.
Participants will complete two, 2-day trials in a random, crossover design separated by at
least 3 weeks to control for the menstrual cycle phase.
On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen
uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline
venous blood sample and endothelial function measurement will be taken. Participants will
consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken
throughout the day at standardised intervals to measure a variety of coronary heart disease
risk markers. A second endothelial function measurement will be completed 2 hours after the
breakfast. Blood pressure will be measured every hour.
It is expected that the South Asian participants will have impaired metabolism and
endothelial function compared to their European counterparts but the bout of exercise
performed on day 1 will mitigate these responses.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 30, 2018 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 18 to 40 year old South Asian and White European women; - Be able to walk continuously for 1 hour; - Weight stable for the past 3 months; - Non-smokers; - No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease). Exclusion Criteria: - Musculoskeletal injury that has affected normal ambulation within the last month; - Congenital heart disease; - Any muscle or bone injuries that do not allow them to walk on a treadmill; - Uncontrolled exercise-induced asthma; - Coagulation or bleeding disorders; - Diabetes (metabolism will be different to non-diabetics potentially skewing the data); - Taking any medication that might influence fat metabolism; - Taking any medication that might influence blood glucose (e.g., insulin for diabetes); - Heart conditions; - Smoking; - Dieting or restrained eating behaviours; - Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment; - A food allergy. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | National Centre for Sport and Exercise Medicine, Loughborough University | Loughborough |
Lead Sponsor | Collaborator |
---|---|
Loughborough University | University Hospitals, Leicester |
United Kingdom,
Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf. — View Citation
Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Triacylglycerol | Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h. | |
Secondary | Endothelial function | Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise. | Day 1 fasting and 8.75h. Day 2 fasting and 3.5h. | |
Secondary | Blood pressure | Changes in blood pressure (systolic and diastolic). | Day 1 fasting. Day 2 fasting and 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h and 9h. | |
Secondary | Glucose | Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 1.5h, 1.75h, 2h, 3h, 4h, 5h, 5.5h, 5.75h, 6h, 7h, 8h and 9h | |
Secondary | Total cholesterol | Fasting plasma total cholesterol on day 1 and day 2 of both trials. | Day 1 fasting. Day 2 fasting. | |
Secondary | Insulin | Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h, 8h. | |
Secondary | High-density lipoprotein cholesterol | Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials. | Day 1 fasting. Day 2 fasting. | |
Secondary | Low-density lipoprotein cholesterol | Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials. | Day 1 fasting. Day 2 fasting. | |
Secondary | Non-esterified fatty acids | Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 1.5h, 2h, 4h, 5h, 5.5h, 7h and 9h. | |
Secondary | Interleukin-6 | Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 3h, 6h and 8h. | |
Secondary | C-Reactive protein | Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2. | Day 1 fasting. Day 2 fasting, 3h, 6h and 8h. | |
Secondary | Peroxiredoxin-4 | Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials. | Day 1 fasting. Day 2 fasting, 3h, 6h and 8h. | |
Secondary | Superoxide dismutase 3 | Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials | Day 1 fasting. Day 2 fasting, 3h, 6h and 8h. |
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